JRCT ID: jRCTs052200030
Registered date:25/06/2020
fNIRS for CI mapping in patients with malformations
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | bilateral severe sensorineural hearing loss |
Date of first enrollment | 30/07/2020 |
Target sample size | 40 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | to determine parameters of electrical stimuli by the cochlear implant on the basis of results of fNIRS measurements in cochlear implant users with inner ear malformations |
Outcome(s)
Primary Outcome | Percentages of electrodes which successfully detect cochlear implant-induced neural responses |
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Secondary Outcome | (1) duration of EABR and fNIRS measurements (2) thresholds determined by EABR, fNIRS, and behavioral measurements (3) adverse effects, diseases, and equipment troubles |
Key inclusion & exclusion criteria
Age minimum | >= 10month old |
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Age maximum | < 18age old |
Gender | Both |
Include criteria | (1) patients having inner ear or internal auditory canal (IAC) malformations and diagnosed as severe or profound hearing loss (2) age at testing ranges from 10 months old to 18 years old (3) patients who underwent cochlear implantation (4) patients who have signed to a written consent-form |
Exclude criteria | (1) patients who can not keep standing still for 3 minutes (2) patients who have severe dermatitis or infection on the head skin (3) patients who the principal investigator or research collaborators have decided to be inappropriate as the participants |
Related Information
Primary Sponsor | Yamazaki Hiroshi |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Utako Shirono |
Address | 2-2 Minatojimaminamimachi, Chuo-ku, Kobe City, Hyogo Hyogo Japan 650-0047 |
Telephone | +81-78-302-4321 |
ushirono@kcho.jp | |
Affiliation | Kobe City Medical Center General Hospital |
Scientific contact | |
Name | Hiroshi Yamazaki |
Address | 2-1-1 Minatojimaminamimachi, Chuo-ku, Kobe City, Hyogo Hyogo Japan 650-0047 |
Telephone | +81-78-302-4321 |
hiroshi_yamazaki@kcho.jp | |
Affiliation | Kobe City Medical Center General Hospital |